The Dietary Education Trial in Carbohydrate Counting (DIET-CARB Study): A Randomized, Parallel, Open-label, Intervention Study Comparing Different Approaches to Dietary Self-management in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
The study is designed to evaluate two different dietitian-led self-management approaches in carbohydrate counting compared to routine dietary care (control) on glycaemic control in adult patients with type 1 diabetes:
- The basic carbohydrate counting concept aims at improving carbohydrate counting accuracy and day-to-day consistency of carbohydrate intake (the BCC intervention)
- The advanced carbohydrate counting concept aims at improving prandial insulin dose accuracy using an automated bolus calculator (the ABC-ACC intervention)
The main hypothesis is that structured training and education in either the BCC concept or the ABC-ACC concept will reduce HbA1c or the average glucose variability more than routine dietary education.
详细描述
The current study is a randomized controlled trial with a parallel-group design. A total of 231 patients will be enrolled in the trial. Participants will be randomized to one of three arms: 1) Basic carbohydrate counting (BCC), 2) Advanced carbohydrate counting with an automated bolus calculator (ABC-ACC), or 3) Standard dietary care.
The primary objective is to evaluate the six months effects of education in the BCC concept and the ABC-ACC concept compared to standard dietary care on glycaemic control as assessed by HbA1c or MAGE (mean amplitude of glycaemic excursions).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 1 diabetes
- •Diabetes duration; >12 months
- •HbA1c of 53-97 mmol/mol
- •Multiple daily insulin injection therapy
- •Provided voluntary written informed consent
排除标准
- •Practicing carbohydrate counting, as judged by the investigator
- •Participated in a BCC group program within the last two years
- •Use of insulin pump, or plans of having an insulin pump within the study period
- •Fixed dose of rapid acting insulin therapy for meals
- •Split-mixed insulin therapy
- •Use of open CGM
- •Use of Freestyle Libre
- •Use of an automated bolus calculator
- •Gastroparesis
- •Pregnancy or breastfeeding, or plans of pregnancy within the study period
- •Low daily intake of carbohydrates (defined as below 25 E% or 100 g/day), as judged by the investigator
- •Uncontrolled medical issues, as judged by the investigator or a medical expert
- •Concomitant participation in other clinical studies
- •Unable to understand the informed consent and the study procedures
研究组 & 干预措施
BCC intervention
The BCC program consists of three group sessions and is delivered by two trained dietitians. In addition to the BCC program, the participants receive regular medical care in the diabetes clinic
干预措施: BCC intervention (Behavioral)
ABC-ACC intervention
The ABC-ACC program consists of one group session and two individual follow-up sessions and is delivered by trained dietitians with supervision by a medical doctor. In addition to the ABC-ACC program, the participants receive regular medical care in the diabetes clinic
干预措施: ABC-ACC intervention (Behavioral)
Standard dietary education
The routine outpatient dietary care consists of three individual consultations delivered by a trained dietitian. The individual guidance is based on the overall treatment goal(s), the defined personal dietary goals for behavioral change which will be in accordance with the patient's needs and preferences. In addition to the dietary counselling, the participants receive regular medical care in the diabetes clinic
干预措施: Standard dietary education (Behavioral)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline, 6 months
mmol/mol
Change in mean amplitude of glycaemic excursions (MAGE)
时间窗: Baseline, 6 months
mmol/l
次要结局
- Changes in % time spent in hypoglycaemia (<3.9 mmol/l)(Baseline, 6 months)
- Change in mathematical literacy(Baseline, 6 months, 12 months)
- Change in intake of dietary fibre(Baseline, 6 months)
- Change in total energy intake(Baseline, 6 months)
- Change in dietary intake of carbohydrates(Baseline, 6 months)
- Change in waist circumference(Baseline, 6 months, 12 months)
- Change in carbohydrate estimation accuracy(Baseline, 6 months, 12 months)
- Change in diet-related quality of life(Baseline, 6 months, 12 months)
- Change in perceived competences in diabetes(Baseline, 6 months, 12 months)
- Change in degree of autonomy-supportive dietitian(Baseline, 6 months, 12 months)
- Change % time spent in hyperglycaemia (e.g. >11.1 mmol/l)(Baseline, 6 months)
- Change in body weight(Baseline, 6 months, 12 months)
- Change in low-density lipoprotein cholesterol (LDL-C)(Baseline, 6 months, 12 months)
- Change in triglycerides (TG)(Baseline, 6 months, 12 months)
- Change in dietary intake of saturated fatty acids (SFA)(Baseline, 6 months)
- Change in dietary intake of monounsaturated fatty acids (MUFA)(Baseline, 6 months)
- Change in free fatty acids (FFA)(Baseline, 6 months, 12 months)
- Change in systolic blood pressure(Baseline, 6 months, 12 months)
- Change in diastolic blood pressure(Baseline, 6 months, 12 months)
- Change in hip circumference(Baseline, 6 months, 12 months)
- Change in time in range (3.9-10.0 mmol/l)(Baseline, 6 months)
- Change in standard deviation of mean plasma glucose(Baseline, 6 months)
- Change in HbA1c(12 months)
- Change in high-density cholesterol (HDL-C)(Baseline, 6 months, 12 months)
- Change in total cholesterol (TC)(Baseline, 6 months, 12 months)
- Change in total fat free mass(Baseline, 6 months)
- Change in total fat mass(Baseline, 6 months)
- Change in dietary intake of total fat(Baseline, 6 months)
- Change in dietary intake of polyunsaturated fatty acids (PUFA)(Baseline, 6 months)
- Change in dietary intake of protein(Baseline, 6 months)
- Change in dietary intake of added sugar(Baseline, 6 months)
研究者
Bettina Ewers
Head of Nutrition
Steno Diabetes Center Copenhagen